Over the past 30 years, the average life expectancy of North Americans has increased by approximately 13 years, contributing to a rapid increase in the number of people over the age of 65. Thus, there has been a dramatic growth in total health care spending as the population ages. As a result, the use of screening and monitoring diagnostics for early intervention, improved treatment and monitoring has become an important aspect of health care.
Technological advances have facilitated the development of easy-to-use, rapid diagnostic devices which can be used in a POC setting, closer to the patient, and that have the ability to pick up disease at an earlier stage. POC testing is attractive because it rapidly delivers results to the medical practitioner and enables faster consultation with the patient. Thus, early diagnosis can enable the practitioner to commence treatment sooner, perhaps leading towards improved patient outcomes. Examples of POC tests include blood chemistry, such as glucose, hematology, immuno-diagnostics, drugs of abuse, serum cholesterol, fecal occult blood test (“FOBT”), pregnancy, and ovulation. In addition many new types of analytics now being carried out in the DNA arena (such as DNA based assays, immuno assays, proteomics and genomics) which are likely candidates for POC testing.
One such example of the potential benefit from a portable medical analyzer in the use of DNA testing is to help doctors prescribe medicine tailored to the particular patient's genotype. Gene-array chip technology determines a patient's genetic information, which a health-care provider may use to classify the patient in particular genotypes. Medications respond differently depending on the particular patient's genotype. By matching the most effective medication for a particular genotype, the patient may receive superior care by avoiding adverse reactions, while maximizing drug efficacy.
A portable medical analyzer provides the additional benefit of facilitating the remote patient monitoring of a patient's medical status. The effectiveness of monitoring systems depends not only on the range of tests reported and their accuracy, but also on the frequency and rapidity of information gathered regarding the patient's health status. A portable medical device can run a range of tests, which cover most of the tests required for diagnosis or therapy monitoring, including blood gases, electrolytes, hematocrit, and various metabolites such as glucose.
Combining biochemical parameter results from the POC device with physiological parameters (such as ECG, respiration rate, temperature and blood pressure) permits integration of vital signs and blood chemistry on a real time basis, for better disease management. Results can then be tracked over time for trend analysis. Portable medical analyzers also have application in the clinical research setting for remote patient evaluation in post surgical recovery, drug therapy and novel pharmaceutical testing using the remote communications ability.
Current POC devices do not provide an integrated solution for patient self-testing to sample acquisition, testing, analysis and connectivity to remote centralized healthcare. Accordingly it is the object of this invention to provide a portable, highly integrated, multi-parameter measurement instrument with IT solutions for data collection, transmission, analysis and on-line decision support. This is achieved by an integrated approach to sample acquisition, a miniaturized multi-parameter low cost test strip or “cartridge,” a companion portable instrument and an information solution for connectivity via a wired or wireless network.